The R&D Tax Credit Aspects of Pediatric Hypertension
Pediatric-Hypertension
Often thought of as a disease of the
middle-aged and elderly, hypertension is increasingly observed
amongst children. The present article will discuss the many
challenges surrounding pediatric high blood pressure as well
as the innovative efforts aimed at developing more effective,
child-specific treatments. It will also present the R&D
tax credit opportunity available to support companies engaged
in overcoming this growing yet often neglected health problem.
The R&D Tax Credit
Enacted in 1981, the Federal Research and
Development (R&D) Tax Credit allows a credit of up to 13
percent of eligible spending for new and improved products and
processes. Qualified research must meet the following four
criteria:
- New or improved products,
processes, or software
- Technological in nature
- Elimination of uncertainty
- Process of experimentation
Eligible costs include employee wages, cost of supplies, cost
of testing, contract research expenses, and costs associated
with developing a patent. On December 18, 2015,
President Obama signed the bill making the R&D Tax Credit
permanent. Beginning in 2016, the R&D credit can be
used to offset Alternative Minimum tax and startup businesses
can utilize the credit against payroll taxes.
High Blood Pressure in
the U.S.
Hypertension is a condition in which the
force of the blood against the blood vessels is higher than it
should be. This pressure is determined by both the amount of
blood pumped and the levels of resistance to blood flow.
There two main types of high blood pressure: 1) essential
hypertension, also known as primary or idiopathic
hypertension, which has no identifiable cause; and 2)
secondary hypertension, which is caused by other medical
conditions, such as abnormalities in the arteries that supply
blood to the kidneys, adrenal gland disorders, sleep apnea,
thyroid and parathyroid problems, amongst others. In 95
percent of high blood pressure cases no apparent cause can be
found.
In the U.S., about 1 in every 3 adults, or nearly 70 million
people have hypertension and are, therefore, at greater risk
for heart diseases and stroke, two of the leading causes of
death in the country, as well as end-stage kidney disease.
Also referred to as the “silent killer” hypertension often
goes unnoticed, due to the absence of symptoms. According to
the Centers for Disease Control and Prevention, only 52
percent of the American adults who have high blood pressure
have their condition under control.
Hypertension has an annual economic
impact of $46 billion in the U.S., which includes healthcare
services, medications, and missed days of work. In 2013, the
condition was listed as the primary or contributing cause to
over 360,000 American deaths, or almost 1,000 per day.
Pediatric Hypertension
Even though high blood pressure is more
commonly observed in adults, it does affect children, which
can suffer from both essential and secondary hypertension.
According to the International Pediatric Hypertension
Association (IPHA), as many as 5 percent of children and
adolescents may have essential hypertension.
The recent rise of high blood pressure rates amongst children
has been linked to the growing prevalence of childhood
obesity. However, even newborn babies can suffer from
hypertension, which is often caused by the exposure to illegal
drugs or inherited predispositions.
There are many challenges and unanswered questions surrounding
pediatric hypertension. However, it is already known that
children who have high blood pressure tend to become
hypertensive adults. It has also been observed that children
with high blood pressure tend to suffer from other medical
conditions, including obesity, high blood lipids, and
diabetes.
Difficulties in diagnosing and monitoring pediatric
hypertension include the absence of a single cut-off above
which a child’s blood pressure is considered high. Instead,
diagnosis is conceived in relative terms – if a patient’s
blood pressure is higher than 95 percent of children of the
same gender, age, and height he is considered hypertensive.
The unreliability of clinic measures, which fail to provide a
comprehensive assessment of different 24-hour blood pressure
patterns, is also a challenge to detecting childhood
hypertension. It frequently overlooks important aspects such
as white coat, nocturnal, diurnal, high-amplitude, and
stress-induced hypertension.
Recent Findings
Pediatric high blood pressure has been
recently linked to rapid weight gain in infants and
preschoolers. In a study that tracked the weight and height of
more than nine hundred babies up to age four, researchers from
the Brigham and Women’s Hospital in Boston found that those
who underwent unusual surges in body mass index before 6
months and between the ages of 2 and 3 had higher blood
pressure in mid-childhood then the ones who experienced
steadier growth.
Though further research would be necessary to assess direct
causality, the findings support the importance of a healthy
diet, particularly breastfeeding, which is linked to a more
linear weight gain than formula feeding.
Another recent study unveiled a connection between allergies,
such as asthma and hay fever, and a greater risk for high
blood pressure and high cholesterol in children. Researchers
from Northwestern University Feinberg School of Medicine
discovered that the cardiovascular risk factors of children
who suffer from these allergic diseases are about twice the
rate of healthy kids.
This finding should encourage parents and doctors to perform
regular screenings of patients with severe allergic
conditions. In the words of Dr. Jonathan Silverberg, an
associate professor of dermatology at Northwestern University:
“Given how common these allergic diseases are in childhood, it
suggests we need to screen these children more aggressively to
make sure we are not missing high cholesterol and high blood
pressure. (…) There may be an opportunity to modify their
lifestyles and turn this risk around."
Child-Specific
Medication
Most guidelines for treatment of pediatric
hypertension recommend lifestyle modifications, such as weight
reduction, regular physical activity, and healthy habits.
However, some cases require the use of medications,
particularly in children with symptomatic or secondary
hypertension, target organ damage, diabetes, or persistent
hypertension.
The absence of comprehensive clinical trials assessing the
patient-oriented, long-term outcomes of antihypertensive
medications in children remains a major challenge when it
comes to determining the best course of treatment. Most
recommendations extrapolate from adult studies, even though
age differences may influence how people respond to therapy.
In this scenario, there is an indisputable necessity of
innovative antihypertensive drugs, specially tailored for the
age, weight, and physical condition of the child taking them.
This advancement is key to promoting safer and more effective
treatments as well as to avoiding harmful overdosing, which
can lead to significant health complications.
Examples of innovation in this domain include the
collaboration between the Institute for Pediatric Innovation,
Beckloff Associates, Children’s Mercy Hospital, Silvergate
Pharmaceuticals, and the University of Kansas, which led to
the development of Epaned, the first oral medicine approved by
the U.S. Food and Drug Administration for use in children with
high blood pressure. Introduced to the market in 2013, the
flavored liquid medicine is specifically designed for small
children aged one month and older. In addition to providing
accurate dosing levels for children, Epaned is easy to swallow
and can, thus, improve adherence to treatment.
The development of safe and effective medicines for children
is an often-neglected area of research. The World Health
Organization stresses the importance of innovative efforts
that take into account the fact that “…children metabolize
medicines differently from adults [and] therefore need
different dosage forms. (…)[also] child-specific medicines
need to be in a format that is palatable to children.”
The growing prevalence of pediatric high blood pressure makes
this especially true for antihypertensive drugs.
Big Data and
Hypertension Research
Technological innovations can open the way
for more effective diagnosis, monitoring, and treatment of
pediatric hypertension. This is particularly true for big data
analytics and the use of electronic health record (HER)
information, which allow for larger and more comprehensive
studies that can potentially shed light on previously unknown
connections.
In 2015, researchers at the Regenstrief Institute and Indiana
University analyzed big data from EHRs between 2004 and 2012
and discovered that the combination of triamterene, a drug
prescribed to conserve potassium in the blood, and
hydrochlorothiazide, a common diuretic, can help lower the
blood pressure in hypertensive patients. According to the
first author, Wanzhu Tu, Ph.D.: “This study is a perfect
example of how we can learn about the previously unknown
therapeutic effects of drugs from big data [and] answer
questions that may otherwise be unanswerable.”
Access to big data is particularly valuable for pediatric
hypertension. Published in 2004, the National Heart, Lung, and
Blood Institute’s Fourth Report on the Diagnosis, Evaluation,
and Treatment of High Blood Pressure in Children underlines
the importance of developing a large national database on
blood pressure levels throughout childhood as a means to
improve the ability to detect hypertension. Over a decade
later, the emergence of EHRs and big data analytics promises
to take this ability to an unprecedented level.
Hypertension
Self-Management Applications
Mobile technology is empowering
hypertensive patients to manage their conditions and allowing
them to establish more effective communication with their
physicians. The number of hypertension self-management apps
has recently surged along with their usage.
According to the website iMedical Apps, common features
include: 1) a medication reminder function, which can
contribute to greater adherence to medical therapy; 2) a
measurement reminder function, which encourages users to
perform regular home blood pressure monitoring; 3) self-care
messages, designed to respond to self-monitoring information
and educate users as to how they could improve their
lifestyle; and 4) automated sharing with the user’s physician.
Some apps also incorporate additional user information, such
as patient’s weight, diet, physical activities, and
medication. By analyzing this data, they help identify
patterns in blood pressure readings and their potential
relation to changes in any one of these aspects.
Smart devices can make hypertension management even
easier. Connected blood pressure monitors
automatically feed data into mobile applications that use it
as basis for the analysis of trends and patterns. Examples
include QardioArm, a clinically validated, wireless monitor
that measures systolic and diastolic blood pressure and
detects irregular heartbeat. Created by San Francisco,
California-based Qardio, Inc., the device is connected to a
mobile application that stores data and use additional
information, such as location, to provide insights on
potential lifestyle choices that could affect the user’s
condition.
Hypertension self-management applications and smart measuring
devices can be particularly helpful for parents willing to
track their children’s blood pressure. The creation of
child-friendly applications for both monitoring and
educational purposes is an emerging trend. Researchers at the
University of California, Los Angeles and the University of
Southern California, for instance, have recently been awarded
$6 million by the National Institute of Biomedical Imaging and
Bioengineering to develop a mobile application for predicting
asthma attacks in children. Though the creation of an
easy-to-use interface for children may be challenging, this
sort of effort can greatly contribute to managing a variety of
pediatric conditions.
Conclusion
Often associated with adult life,
hypertension in children has often been overlooked. The
indisputable growth in prevalence, however, has shed light on
the importance of creating child-specific treatments and
monitoring tools. Companies investing in new drugs and
technology targeted at pediatric high blood pressure should
take advantage of R&D tax credits to increase their
chances of success.
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